UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006001 |
|---|---|
| Receipt number | R000007099 |
| Scientific Title | Evaluation of the efficacy and the safety of soy protein on human muscle metabolism. -On the inpatient. |
| Date of disclosure of the study information | 2011/07/26 |
| Last modified on | 2025/03/19 16:22:12 |
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Basic information
Public title
Evaluation of the efficacy and the safety of soy protein on human muscle metabolism.
-On the inpatient.
Acronym
Clinical trial of intake of soybean protein ingredients.
-On the inpatient.
Scientific Title
Evaluation of the efficacy and the safety of soy protein on human muscle metabolism.
-On the inpatient.
Scientific Title:Acronym
Clinical trial of intake of soybean protein ingredients.
-On the inpatient.
Region
| Japan |
Condition
Condition
Inpatient
Classification by specialty
| Neurology | Orthopedics | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and the efficacy of soybean protein ingredients on muscle atrophy.
On the inpatient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Sectional area of large hamstring muscles
2)Marker of muscle athropy(3Met-His,CK)
3)Marker of oxidative stress(8-OHdG)
4)Muscle strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Soybean protein ingredient
Interventions/Control_2
Powdered cazein
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The inpatient
2)Subject with Performance Status(PS)2 or 3
3)Subject must be aged =>20 years.
4)Both men and women
5)Subject who consent to participate in this study in person.
Key exclusion criteria
1)Primary muscle disease
2)Chronic kidney disease
3)Diabetes mellitus
4)Subject who use any medication of the muscle.
5)Subject who have soybean allergy and milk allergy.
6)Subject who take the health food supplement including the soybean.
7)Pregnant female, lactating female
8)Subject who can't undergo MRI scan.
9)Subject who have been enrolled in this study within the last 2weeks.
10)The case that subject refuse to participate in this study.
11)The case that it is difficult to participate in this study in the opinion of the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
The University of Tokushima
Division name
Graduate School of Nutrition and Bioscience -Nutritional Physiology
Zip code
770-8054
Address
3-18-15Kuramoto-cho, Tokushima
TEL
088-633-9248
nikawa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
The University of Tokushima
Division name
Graduate School of Nutrition and Bioscience -Nutritional Physiology
Zip code
770-8503
Address
3-18-15Kuramoto-cho, Tokushima
TEL
088-633-9247
Homepage URL
nikawa@nutr.med.tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
1)National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
0886339295
first-ec@tokushima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
https://doi.org/10.2152/jmi.62.177
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.2152/jmi.62.177
Number of participants that the trial has enrolled
59
Results
Results : Thirty-day soy protein supple
mentation significantly increased skeletal muscle volume in participants with low physical activity, compared
with 30-day casein protein supplementation. Both casein and soy protein supplementation increased the volume
of quadriceps femoris musclein bedridden patients. Consistently, soy protein significantly increased their ex
tension power of the knee, compared with casein protein.
Results date posted
| 2025 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Background:Inrecentyears,thenumberofbedriddenpeopleisrapidly increasing due to aging or
lack of exercise in Japan. This problem is becoming more serious, since there is no countermeasure against it. In
the present study, we designed to investigate whether dietary proteins, especially soy, had beneficial effects on
skeletal muscle in 59 volunteers with various physical activities
Participant flow
Methods : We subjected 59 volunteers with vari
ousphysicalactivities to mealintervention examination.Personswithlowandhighphysical activities were
divided into two dietary groups, the casein diet group and the soy diet group. They ate daily meals supplemented
with 7.8 g ofpowderedcaseinorsoyproteinisolateevery day for30days. Bedridden patients in hospitals were
further divided into three dietary groups : the no supplementation diet group, the casein diet group and the soy
diet group. They were also subjected to a blood test, a urinalysis, magnetic resonance imaging analysis and muscle
strength test of the knee before and after the meal intervention study
Adverse events
None
Outcome measures
1)Sectional area of large hamstring muscles
2)Marker of muscle athropy(3Met-His,CK)
3)Marker of oxidative stress(8-OHdG)
4)Muscle strength
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2011 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007099
